NCT00011999

Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer

Phase II Early Postoperative Paclitaxel Followed By Paclitaxel And Cisplatin Concurrent With Radiation Therapy For Resected, High Risk Squamous Carcinoma Of The Head And Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy following surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have undergone surgery for stage III or stage IV head and neck cancer.

Detailed description

OBJECTIVES: * Determine the feasibility of adjuvant paclitaxel followed by radiotherapy with concurrent paclitaxel and cisplatin in patients undergoing gross complete resection of high-risk stage III or IV squamous cell carcinoma of the head and neck. * Determine the disease-free and overall survival of patients treated with this regimen. * Determine the acute and chronic toxicity of this regimen in these patients. * Determine the patterns of failure in patients treated with this regimen. OUTLINE: Patients receive adjuvant therapy beginning 7-14 days after gross total surgical resection. Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15. Beginning on approximately day 22, patients undergo radiotherapy once daily 5 days a week for 5.5-6.5 weeks. Patients also receive paclitaxel IV over 1 hour followed by cisplatin IV over 1-3 hours on days 43, 50, and 57. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 11 months.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	paclitaxel
PROCEDURE	conventional surgery
RADIATION	radiation therapy

Timeline

• Start date: 2001-03-01
• Primary completion: 2004-02-01
• Completion: 2010-06-01
• First posted: 2003-01-27
• Last updated: 2015-11-17

Locations

234 sites across 2 countries: United States, Canada